Global plasma derived medicine market growth can be hampered due to presence of stringent regulatory frameworks governing the manufacturing and approval of plasma derived medicines. The production of plasma derived medicines involves collection of human plasma, which raises several safety and ethical concerns. To ensure the safety of plasma collection process and final medicines, regulations bodies across countries have implemented strict rules for plasma collection centers and manufacturers. Complying with various international standards such as cGMP further increases the production and operating costs for market players. Obtaining regulatory approvals for new plasma derived drugs or significant changes to the existing manufacturing processes has also become a time-consuming process due to complex standards. The cumbersome regulatory conditions can delay the market entry of new products and significantly affect the revenue generation capabilities of companies.
Market Opportunity: Production of hyperimmune immunoglobulins
The production of hyperimmune immunoglobulins can offer growth opportunity for players in the global plasma derived medicine market. Immunoglobulins are antibodies that are derived from blood plasma of donors with high antibody count against specific diseases. Hyperimmune immunoglobulins are immunoglobulin preparations produced from plasma specifically collected from donors with high levels of antibodies against targeted diseases. Increasing production of hyperimmune immunoglobulin products for different indications can offer growth opportunities. For example, manufacturers can focus on developing and commercializing hyperimmune products for diseases like rabies, hepatitis B, varicella zoster and tetanus, where immunoglobulin therapy delivers high clinical effectiveness. With growing spending on healthcare and emphasis on developing targeted therapies, there will be huge demand for hyperimmune immunoglobulins in the near future.
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